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Groups Potentially at Risk for Making Poorly Informed Decisions About Entry into Clinical Trials for Childhood Cancer

Christian Simon, Stephen J. Zyzanski, Michelle Eder, Pauline Raiz, Eric D. Kodish, Laura A. Siminoff

From the Rainbow Center for Pediatric Ethics, Department of Pediatrics, and Rainbow Babies’ and Children’s Hospital of University Hospitals of Cleveland, Cleveland, OH

Address reprint requests to Christian Simon, PhD, Case Western Reserve University Comprehensive Cancer Center, 11100 Euclid Ave, Cleveland, OH 44106-5065; email: cxs66{at}po.cwru.edu.

Purpose: Some patients may be at greater risk than others of enrolling on a randomized clinical trial (RCT) without fully understanding the implications. To investigate this possibility, this study poses the question, Do non–English-speaking Latino parents of children with leukemia show differences in their discussion of and understanding of an RCT when compared with English-speaking minority parents and with English-speaking majority (ie, white) parents? This research hypothesizes that factors such as social and educational status and the role of language interpreters may account for significant differences in the discussion and understanding of an RCT among the three groups.

Patients and Methods: A total of 108 parents are reported on, all of whom were observed, interviewed, and audiotaped during informed-consent discussions about participation in an RCT with their child’s oncologist. Comparisons among the groups were performed using ² tests and a one-way analysis of variance.

Results: Problems of consent-related communication and understanding were more frequent among parents of low social status who spoke little or no English than they were in the two other groups. Several factors may have contributed to this disparity, including language interpretation, social status, and prevailing cultural norms.

Conclusion: Some patients may be at greater risk than others of enrolling on an RCT without fully understanding the implications of their decision to do so. Numerous factors may contribute to this disparity, including language interpretation, social status, and prevailing cultural norms. Some specific strategies are suggested to help address this disparity.

This study was supported in part by Rainbow Babies and Children’s Hospital Board of Trustees and the National Cancer Insitute-funded study "Informed Consent in the Children’s Cancer Group" (R01 CA83267).

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